The U.S. Food and Drug Administration has announced the investigation of EpiPen, manufactured by Meridian Medical Technologies. The manufacturer is a subsidiary of Pfizer, responsible for the auto injector component in EpiPen. 171 complaints dating back to 2014 report the pens’ total failure to activate when needed, resulting in a number of patient deaths. Because EpiPens are a last resort medical device used in a time of crisis, even a slight defect can lead to disastrous complications–including death.
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EpiPen has been issued a FDA warning primarily because of its auto-injector. Reports have described the auto-injector as unable to function in emergency situations, thus not allowing patients to access the epinephrine, as it remains in the device. EpiPens have also reportedly begun to spontaneously leak epinephrine before the device is ever administered, causing patients to receive too little epinephrine, or none at all.
EpiPen is only one brand of epinephrine auto-injectors on the market. While Meridian Medical Technologies manufactures the pens, they are marketed and distributed by pharmaceutical giant Mylan Specialty, L.P. As a result of the FDA investigation, Meridian Medical technologies has issued a recall.
The company recalled the following lots of the EpiPen Jr. Auto-Injector (0.15 mg):
Additionally, Meridian medical also recalled the EpiPen Auto-Injector (0.3 mg), and the following lots:
Around 3.5 million consumers rely on EpiPens to save their lives, which is why this oversight by Meridian Medical Technologies is incredibly reckless and potentially fatal. If you or a loved one has experienced the failure of EpiPen, it is highly recommended you seek out legal counsel. At Rheingold Giuffra Ruffo & Plotkin LLP, we have years of experience litigating defective medical devices suits and are committed to recovering compensation for our clients’ suffering.
To schedule an initial consultation with a member of our firm, please don’t hesitate to contact us by calling (212) 684-1880.