06222017Headline:

Gadsden, Alabama

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Michael Roberts
Michael Roberts
Attorney • (256) 543-0400

Did Company Know of Sterility Problems Before It Sold Contaminated Steriod Medical Products?

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The national concern over fungal infections took another interesting turn this week as the Food and Drug Administration (FDA) released a report on inspections conducted at a Massachusetts pharmacy known to be the center of the outbreak. The FDA now points to the New England Compounding Center’s monitoring mechanisms showing of multiple instances of bacterial and fungal contamination of two supposed “clean rooms”, dating back to almost nine months prior to the outbreak of meningitis caused by the drugs distributed from the Center.

The Center’s drugs are now appear to be responsible for 338 infections in 18 states, with fungal infections ranging from meningitis to stroke, as well as infections of knees, elbows, and other joints. For twenty five individuals, the infection was fatal. Steven Lynn, a representative of the FDA, stated that “investigators observed that no documented corrective actions were taken when the firm’s own environmental monitoring showed microbial contamination above its action limit”. These action limits are measurements of contamination which exceed the standard of a “sterile environment”. In many cases for the New England Compounding Center, the microbial dishes were literally overflowing with bacterial, and visible to the naked eye. Among the other issues with the “Clean rooms”, were puddles of green and yellow stagnant water in sterilization equipment, wet floors and surfaces around prep rooms, and other incidences of clearly unsanitary practices.

These findings about the Center’s disregard for sterility practices, and its understanding of the contamination and utter failure to act is the most alarming news surrounding the controversy to date. The implication of these findings is unknown, but a criminal investigation surrounding the cente has been opened, and many are accusing the Center of misleading state officials about facts surrounding the manufacturing and shipping of the drugs.

With the number of affected individuals increasing, it is important to take a moment to consider the medications you are taking, and complications that you may be experiencing as a result. Being aware of any symptomatic responses to medication, and the effects your medication and injections have on your body are an important step to staying healthy. If you believe that you may be suffering from any complications due to your currently prescribed medication, or if you believe that you may have been exposed to contaminated medication produced by the New England Compounding Center, it is important to seek medical advice.