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FDA links 7 deaths to faulty EpiPens

Anaphylaxis is a severe, and possibly life-threatening, allergic reaction that can occur just seconds after an individual has been exposed to an allergen. Immediate treatment is crucial in these situations, and many New York residents who suffer from serious allergies rely on devices like the EpiPen to deliver measured doses of epinephrine quickly and simply. EpiPens are designed to be easy to use for those with no medical training, but they have been connected with seven fatalities so far in 2017 according to the Food and Drug Administration.

In addition to the seven deaths, the FDA says that 35 individuals required hospital treatment after their EpiPens malfunctioned. The pharmaceutical company that manufactures the EpiPen and EpiPen Jr. says that the defect responsible for the failures is extremely rare and problems should be expected when medical devices are used by people who have not been properly trained, but the FDA data reveals a worrying increase in EpiPen failures during the last few years.

The FDA received only four reports about malfunctioning EpiPens in 2012 and 12 in 2013, but that figure increased worryingly to 67 in 2014 and is likely to exceed 300 in 2017. However, the FDA is quick to point out that adverse event complaints about malfunctioning medical devices do not necessarily mean that the devices involved failed. The cause of the reported EpiPen failures has yet to be determined, but leaking epinephrine could be to blame. The FDA sent a warning letter to the manufacturer after inspectors found leaking EpiPens while inspecting a Missouri plant in September.

Experienced personal injury attorneys may study FDA complaints and the resulting actions taken by the federal safety agency when preparing litigation on behalf of those who have been harmed by malfunctioning medical devices. The defendants in these cases often point the finger of blame at consumers, but this may be more difficult to do when a government watchdog has found evidence of negligence or malfeasance.

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