The meningitis outbreak associated with epidural steroid injections produced by the New England Compounding Center (NECC) has hit yet another state. According to the U.S. Centers for Disease Controls (CDC), 328 cases of fungal infections in 18 states are now suspected of being linked to the contaminated steroids. The case count includes 323 reports of fungal meningitis in people who received steroid shots in their back, and five cases of peripheral joint infections in patients who had NECC steroid injections in their knees, shoulders or ankles.

NECC is already facing a number of fungal meningitis lawsuits filed in federal courts around the country. Last week, several plaintiffs motioned the U.S. Judicial Panel on Multidistrict Litigation to consolidate the meningitis lawsuits in federal court in Minnesota.

NECC’s epidural steroid injections were shipped to 76 pain clinics in 23 states. According the CDC, all but five of those states have now reported fungal infections. Twenty-four deaths have been blamed on the meningitis.

NECC recalled epidural steroid injections on September 26th, then surrendered its license to operate and recalled all of its products on October 6th. The outbreak of fungal infections has prompted calls for criminal charges against Framingham, Massachusetts-based NECC, and raised questions about the oversight of compounding pharmacies, which prepare customized medications for individual patients. In the case of the epidural steroid injections, it appears NECC may have been acting as a pharmaceutical manufacturer, which would have been a violation of the law, according to Massachusetts health authorities.

According to a report from the Associated Press, NECC was nearly reprimanded by Massachusetts regulators in 2004, but escaped sanction after the company complained they would prove fatal to its business. At the time, complaints against NECC included a failure to meet accepted standards for making the same steroid that’s been connected to the outbreak. According to the Associated Press, Massachusetts officials had proposed a Consent Decree to resolve the complaints that included the reprimand and a three-year probationary period for the company’s registration and owner Barry Cadden’s license. The case ended without disciplinary action as part of a different consent agreement reached with the board in 2006. The agreement was signed under then-Gov. Mitt Romney’s administration.

Loyd V. Allen Jr., editor of the International Journal of Pharmaceutical Compounding, told the Associated Press that the three-year probationary period called for by the original consent decree indicates the complaints NECC was facing were serious. He further posited that the company’s pleas to regulators that a reprimand would harm its business should not have carried any weight.

“Whether or not it’s going to be hurtful or harmful to the business shouldn’t really be the issue if patient safety is on the line,” Allen said.

Published October 25, 2012 by