Inspira Health Network did not pull all doses of a drug that had been recalled due to being connected to outbreaks of fungal meningitis in 2012. Now the company faces $10,000 in fines for that failure. Four patients at Inspira medical facilities were given doses of the medication in question, and they were put at risk of developing the potentially deadly infection.
The U.S. Food and Drug Administration (FDA) announced a recall of several products from the New England Compounding Center (NECC) in October of 2012. Investigations into the company found that it had been operating as a drug manufacturer, as opposed to simply filling prescriptions, a violation of its license from the state of Massachusetts. Ultimately, 14 people from NECC would be indicted for a range of charges, including sending out drugs that they knew could be mislabeled or contaminated and second-degree murder.
The recall came after outbreaks of fungal meningitis, an infection of the meninges, the membrane that covers the brain and spinal cord, were seen in several states. The first outbreak was traced by the Centers for Disease Control and Prevention (CDC) to methylprednisolone, a drug used in steroid injections. The questionable lots, linked to the outbreak, came from NECC. During subsequent FDA investigations, several vials of the medications were found to have fungal matter in them. The FDA recalled the methylprednisolone and several other injectable medications made by NECC.
Inspira Pulls Recalled Drugs
Inspira Health Network acted on the recall and pulled the methylprednisolone from its shelves, but failed to pull all of them. According to the company, the recall announced by NECC did not mention which vial sizes were involved and contaminated. Inspira claimed to have information from past recalls that led them to believe only the five milliliter vials were potentially contaminated. They failed to remove one milliliter vials and some of these were used on patients.
Four patients at Inspira facilities received injections of the one milliliter vials of methylprednisolone that should have been recalled. Inspira put patients at risk of developing fungal meningitis by failing to accurately follow through with the recall orders. Those four patients were carefully monitored and were not found to have been adversely affected by the injections. Patients with weakened immune systems are most at risk of developing fungal meningitis, so not all those exposed to the contaminated drugs were sickened.
The state of New Jersey, where Inspira is located, investigated the health company over the incident and fined it $10,000 plus an additional $5,227.99 to cover the costs of the investigation. Inspira also agreed to review and update its recall procedures to make sure that a similar mistake will not happen in the future.
The meningitis outbreak that occurred as the result of faulty and contaminated medicines from NECC resulted in 751 people becoming ill and 6 people dying because of a serious infection. The problem began with NECC, but it continued with companies like Inspira that put even more people at risk after the recall was issued. The fine serves as punitive damages for Inspira, but also as a warning to other companies to be careful when responding to recalls.