Photo: Sarah D / flickr
As a national public health crisis develops across the country due to an outbreak of fungal meningitis, lawyers in Minnesota have filed a class action against the company that compounded, or mixed, the steroid medication that has sickened 214 and killed 15 people.Barbe Puro of Minneapolis received an injection on Sept. 17 of methylprednisolone acetate made by the New England Compounding centre (NECC). She later developed headaches and nausea; then the Minnesota Department of Health called and told her she’d received a contaminated steroid and needed to see a doctor because she might have fungal meningitis.
Puro called a lawyer, who quickly filed a lawsuit in federal court and is trying to get a class certified in Minnesota. At this point, only five cases have been reported in the state, but there could be many more – in Minnesota and elsewhere. According to one report, public health officials have contacted 12,000 of the roughly 14,000 people who received the steroid shots at clinics in 23 states.
Jeffrey Montpetit, a lawyer with Sieben, Grose, Von Holtum & Carey in Minneapolis who represents Puro, says the suit is both a products liability and personal injury action that alleges negligence on the part of NECC. “Puro is seeking monetary compensation,” he confirms, “but there is also a generalized public health aspect to the case.”
Montpetit says he hopes to let people know that if they’ve had these injections – which were given in the spine for back pain and inflammation – they need to see a doctor. “The earlier you deal with it, the better chance you have of having a full recovery,” he says.
In addition to headaches and nausea, fungal meningitis can be marked by fever, slurred speech, and neck stiffness. Some patients have experienced strokes. Fungal meningitis is not contagious, but can be very dangerous because they are slow to develop.
People who sought these steroid injections were likely already dealing with pain before being exposed to fungal meningitis, notes Montpetit. They could easily write off any new symptoms of this very dangerous disease as related to the chronic pain they’ve become accustomed to. “Whether they have symptoms or not, it’s important to get in and see their health care providers,” he says.
Multiple Agencies Investigating
The federal centres for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and state health departments across the country are investigating the outbreak, which has spread to 15 states. A Massachusetts Congressman is calling for new regulations on compounding pharmacies, which are not currently regulated by the FDA.
The FDA expanded its investigation on Oct. 15 to include other drugs produced by NECC. The agency is worried that injections given to eye surgery and heart patients might also have been contaminated.
NECC recalled the steroid compound on Sept. 26 and announced a recall of all its products on Oct. 6. It says it is cooperating with the investigations.
New Regs for Compounders on the Way?
Pharmacists at compounding pharmacies mix custom drugs from many different active ingredients, and their services have been in higher demand recently because they can offer hospitals and doctors medications at cheaper prices than those charged by pharmaceutical companies, according to a recent report in TIME.
“Right now, compounding pharmacies are governed by patchwork regulations, with federal and state agencies engaging in piecemeal oversight,” said Congressman Edward J. Markey (D-Mass.). “This is unacceptable. Congress must act immediately to address these gaps in the fragmented regulatory system over compounding pharmacies.”
Markey wants a new law that would, among other things, require compounding pharmacies to comply with minimum safety standards and ban them from using ingredients not approved by the FDA.
How the pharmacy put the medication together will be the heart of the case against NECC, confirms Monpetit. “We’re not at liberty to talk about it because of the ongoing litigation, but [compounding] is exactly where we feel the wrongdoing lies,” he says.
If you received a steroid injection or have been contacted by your state health department, see a doctor; if you’re concerned about bringing a suit, contact a products liability or personal injury lawyer on Lawyers.com.
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