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FDA Provides More Information at Problems at Meningitis Outbreak Drug Plant

Over the weekend various news outlets reported on the latest results from the U.S. Food and Drug Administation’s (FDA) investigation into the New England Compounding Center (NECC)–the “drug mixing” pharmaceutical plant at the center of the fungal meningitis outbreak that has swept large parts of the country. As we’ve shared frequently, several hundred medical patients–including some in Illinois–have developed funal meningitis as a result of contaminated spinal steroid injections given at local pain centers. Considering the seriousness of the outbreak, which has thus far taken the lives of at least two dozen people, state and federal regulators have intensely scrutinized the involved facility to determine the scope of the problem.

FDA Investigation into Meningitis Outbreak
According to an article on the situation from the Wall Street Journal, the FDA report offers a glimpse into obvious problems at the NECC. For one thing, the story notes that about one-fourth of the vials examined by federal regulators had very obvious greenish black material in the vials. At leat fifty vials were ultimately sent to the lab for closer investigations. Those results found that, shockingly, all fifty of those vials were contaminated with fungus. Over 17,000 vials of the spinal steroid were ultimately sent out to clinics in at least twenty three different states. At leat 14,000 of those vials may have been used before they were recalled in Septmber. And what these latest reports indicate is that those contaminated vials were not just flukes–the sterility problems at this facility were widespread.

It should come as no surprise then that all of the products made around that time by the NECC have since been recalled. In addition, all plant operations have been shut down. It is unclear if the NECC will be shut down permanently, but, at the very least, the obvious safety problems at the compounding center make it impossible for products to be made there without risk of harm. It also raises questions about the safety of similar compounding plants.

This latest FDA report comes on the heels of a state investigation into the NECC which similarly found widespread cleanliness and sterility problems. In fact, records reveal that NECC officials themselves identified possible sterilization isssues in several “clean rooms” at the plant as early as January. Bacteria was allegedly found in those locations. Yet, from the records obtained thus far, there is no indication that the bacteria problems were ever resolved. On one hand it is encouraging that the NECC conducted some sort of internal investigation to check on safety issues. But that checking is of no value for patient safety is the recognized bacteria problems are not acted on.

This is perhaps another example of a business choosing to focus on its own best business interests, even when that means risking the safety of those using their products. Our injury attorneys are familiar with companies choosing to maximize their own profit over the well-being of others–as nursing home operators sometimes do. And that is why we continue to fight for the rights of those harmed by these negligent actions. Accountability must be demanded following these incidents both as a matter of basic justice and a reminder to all businesses that they must act reasonably at all times or risk paying the consequences of the harm they cause.

See Our Related Blog Posts:
The Personal Stories Behind the Meningitis Outbreak

New Details on Past Problems at Pharmacy Behind Meningitis Outbreak