Over the past few weeks you may have heard about the high-profile spinal steroid contamination and the subsequent fungal meningitis outbreak. For those first hearing about this ordeal–which has so far affected patients in 19 states, including Illinois–the Centers for Disease Control and Prevention website on the situation is a good first place to look for information.
The outbreak has been traced to poor sanitation and cleanliness issues at the New England Compounding Center (NECC). This is a “compouding” pharmacy, meaning that the company takes materials made elsewhere and combines them to create appropriate doses of material for use in medications. Earlier this year over 17,000 vials of a spinal steroid made it out of the facility that were contaminated with a fungs. Nearly 14,000 of those vials may have been given to patients before the problem was uncovered. As a result, hundreds developed a very rare and serious fungal meningitis.
According to the CDC, the current infected count is at 480 patients. In addition, there have been 33 deaths links to the outbreak. Most of those deaths were caused by strokes that the patients who developed the meningitis suffered. The meningitis is thought to have spurred the strokes. All told, at least two people in Illinois are among those who developed the condition as a result of the contaminated steroid injection.
As you might expect, in the aftermath of this fiasco there has been significant attention drawn to the compounding pharmacy at issue. Many influential policymakers–including many members of Congress–have been asking hard questions about how something of this magnitude could occur. The rise of the problem has shone new light on currently regulatory schemes that affected these types of pharmacies. In particular, some have wondering if toughter oversight is necessary. Right now, these unique pharmacies are mostly out of federal regulatory purview, and are instead managed by individual states. However, each state has different standards and the quality of regulatory enforcement on the state level varies considerably.
In fact, according to a recent NBC News story, the U.S. Food and Drug Administration has warned Congress that an outbreak on this scale could happen again. The problem, say FDA officials, is that their office has little knowledge about where these compounding facilities are located, what medications they are making, and how they are making them. Nonetheless, many have already pointed fingers at regulatory agencies at all levels, wondering why little was done to stop the NECC from operations, even though there were signs early on of quality control problems. One of the main concerns regards how the facility was able to continue operations, even though it was violating the law. Most notably, the company was engaging in wholesalw creation and distribution of certain drugs–like the steroids in this case. However, the facility’s license did not technically allow that type of work. Instead, they were supposed to only be filling prescriptions that were called for: not selling in bulk to clinics.
Please contact the meningitis outbreak attorneys at our firm in Illinois to learn more abou the legal ramifications of this situation in Chicago and throughout the state.
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