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How the Outbreak Happened: Compounding Firm’s Poor Track Record

So how exactly did this fungal meningitis outbreak happen? Was it an innocent mistake that could not have been prevented? Are the risk factors that caused this accident the same that affect other pharmaceutical compounding plants across the country? Is there anything that can be done to ensure no more families are forced to endure what thousands are enduring now in the wake of this deadly spinal steroid contamination?

These and similar questions are being asked by invovled parties across the country. We need to get to the bottom of this fiasco while ensuring all those affected are supported and those accountable are held to task.

It is far too early to make any definitive statements about this exact case. However, investigators, including many from the U.S. Food and Drug Administration as well as intrepid individual researchers, have uncovered details about the history and goings-on at the compounding plant. The information presented thus far is not pretty.

Past Pharmacy Safety Problems
For example, a recent Journal Gazette story discussed how state investigators released information about terrible conditions aneara “cleaning room” in the now-temporarily closed facility. They noted that there was a leaking boiler near the room, an obvious safety risk. On top of that, visible black specks of fungus were found inside steroids in the plant. In addition, thousands of the contaminated products were apparently sent out by the company before test results came back on the safety of the steroids. This is what allowed the problem to occur.

The state has already moved to take some preliminary action in the case. Steps have been initiated to revoke the license of the facility as well as the licenses of three individual pharmacists who were allegedly linked to the disaster. Yet, the governor of the state where the plant is located made clear that these preliminary steps were still insufficient. He has already made calls for changes which allow more oversight of these facilites, including the ability to make more surprise inspections. As in the case of nursing home quality standards, the ability to take important steps like surprise inspections is a crucial way to ensure the full weight of state power is put to bear to mandate reasonable safety standards.

Legal Accountability
Obviously the patients who received the shots hundreds of miles away from this plant would never suspect that the drug that their clinic gave them would have been created in such deplorable conditions. However, because of the decentrilized nature of our consumer system today, these sorts of situations are liable to happen when certain actors (like pharmaceutical companies) do not prioritize safety. It is simply impossible for patients (or sometimes even the doctors who receive the drug shipments) to be able to individually identify the risk of contamination. There is no way to operate without some trust in the manufacturing process.

This is one of many reasons why it is absolutely essential for misconduct in these situations to be handled strongly. When makers of these products violate the trust they are given–usually in an effort to cut corners and maximize profits–they are responible for the harm that results. To ensure that there is accountability in your individual case, please take a moment to reach out to the meningitis outbreak lawyers and product liability attorneys at our firm who can help ensure your rights are respected every step of the way.

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