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Epipen Makers Accused of Failing to Investigate Defective Devices

EpiPens can be a lifeline in deadly situations. An EpiPen directly injects epinephrine, immediately alleviating life-threatening allergic reactions. With so much at stake, it is important that the device functions correctly. However, the makers of EpiPen have been accused by the FDA of neglecting to investigate malfunction complaints.

EpiPens failed to activate in situations ending in death

The FDA released a warning letter this month stating that Pfizer, manufacturer for the drugmaker Mylan, failed to investigate over 171 complaints from consumers. Complaints from 2014 to 2017 state that the device failed to activate in emergencies, including situations ending in death.

Pfizer said in a statement that they did recall a batch of defective injectors in March, but are unaware of any defective products currently on the market. They claim there is no evidence to connect complaints and consumer injuries. While the company assures that consumers are safe, the FDA paints a darker perspective in their letter.

The FDA letter indicates that Pfizer did not initially recall potentially defective EpiPen lots even after identifying the issue. The company later recalled some products after prompts from the FDA. The FDA hopes that the warning letter will provoke the manufacturer to properly investigate complaints and make necessary modifications.

How should consumers react?

President of the National Center for Health Research said in a Washington Post article that the FDA letter is uncharacteristically blunt. She stated that it will “raise concerns for parents and patients who depend on the EpiPen.”

This information is troubling for anyone managing severe allergies. While defective EpiPens currently on the market may be rare, any defect could be life-threatening. EpiPen consumers should toss any EpiPens that are recalled or past their expiration date. It is recommended that people who rely on the device should carry two EpiPens at all times.

Consumers have a right to expect that the products they purchase will be safe. Unfortunately, some companies choose to profit from dangerous products while risking their customers. People suffering physical harm or monetary damages from defective products may be able to recover compensation by contacting an attorney.


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We are dedicated to supporting families during the most challenging times, with a focus exclusively on cases involving catastrophic injuries or the loss of a loved one. Please reach out if you have any questions. We look forward to speaking with you.

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