A $100 million settlement agreement has been reached over a deadly fungal meningitis outbreak that sickened hundreds and killed more than 60 people in late 2012 and early 2013, which was linked to tainted epidural steroid shots distributed by a Massachusetts compounding pharmacy.
The owners of the New England Compounding Center (NECC), its insurers, and some associated medical companies have agreed to put about $100 million into a victim compensation fund for those who developed fungal meningitis after receiving contaminated epidural steroid injections.
The injections were sent out by the pharmacy over the summer of 2012 and an epidural steroid injection recall was announced that fall when the contamination was discovered.
The fungal meningitis outbreak sickened more than 700 people, with new cases of infection continuing to surface for more than a year after the vials were pulled from the market. Investigators estimate that more than 17,000 of the contaminated shots were distributed to hospitals and pain centers nationwide for the alleviation of back pain, with an estimated 14,000 patients were exposed to the shots.
In the wake of the recall and lawsuits filed on behalf of individuals nationwide, NECC filed for bankruptcy protection and many have been concerned about the lack of resources to adequately compensate all of the victims.
At least 64 people died in the fungal meningitis outbreak, and more than 751 cases were identified in 20 different states, as of October 2013. Following the outbreak, sweeping changes in how compounding pharmacies nationwide are regulated
Reports suggest indicate that NECC’s owners, Barry and Lisa Cadden, and Greg and Carla Conigliaro, have put $50 million into the settlement. The related company Ameridose and NECC’s insurers have placed another $25 million. Ameridose is also up for sale, and when and if that sale happens, the fund will receive another $10 million from the proceeds. Preliminary details of the settlement were first announced in December.
Attorneys for the victims indicate that they still hope additional contributions will be obtained from other companies linked to the outbreak, including UniFirst, which oversaw contamination control and NECC, and some doctors and pain centers who gave out the shots, which reportedly had visible fungus floating in the vials in some cases.
Despite the NECC fungal meningitis settlement agreement and investigations into the company’s operations, which uncovered unsterile drug manufacturing conditions that included the exact same strains of fungus and a long track record of violations that went unpunished, the former owners of the compounding pharmacy continue to deny responsibility for the illnesses and deaths.
The settlement is not likely to end the fungal meningitis litigation, as there are additional parties that may be liable for the injuries suffered by people who received the contaminated injections, including pain clinics and hospitals where the shots were given to patients, as well as the doctors who administered or advised patients to have them.