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A Pfizer unit that makes the EpiPen device for Mylan experienced a quality-control meltdown that included a failure to investigate “serious” problems associated with an unspecified number of patient deaths.

Throughout last year, Meridian Medical Technologies received hundreds of complaints that the EpiPen device, which is used to combat serious allergic reactions, failed to operate during life-threatening emergencies. Yet the Pfizer manufacturing unit not only failed to thoroughly investigate the problem, but did not initially remove potentially defective products.

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